A Study of CyPass Implantation In Patients With Open Angle Glaucoma Refractory to Single or Multi-agent Topical Therapy (DUETTE)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Transcend Medical, Inc..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Transcend Medical, Inc.
ClinicalTrials.gov Identifier:
NCT01166659
First received: July 14, 2010
Last updated: July 3, 2012
Last verified: July 2012
  Purpose

This study is to evaluate the safety and effectiveness of CyPass implantation for lowering intraocular pressure in patients with primary open angle glaucoma (POAG) who have failed at least one class of topical medical therapy.


Condition Intervention
Primary Open Angle Glaucoma (POAG)
Device: CyPass 2FX Micro-Stent

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Comparative, Multicenter Clinical Study to Assess the Safety and Effectiveness of CyPass Implantation in Patients With Open Angle Glaucoma Refractory to Single or Multi-Agent Topical Therapy

Resource links provided by NLM:


Further study details as provided by Transcend Medical, Inc.:

Primary Outcome Measures:
  • Intraocular pressure (IOP) reduction [ Time Frame: 12 months postoperatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Achievement of target intraocular pressure (IOP) with and without use of ocular hypotensive medication [ Time Frame: 12 months postoperatively ] [ Designated as safety issue: No ]
  • Ocular hypotensive medication use [ Time Frame: 12 months postoperatively ] [ Designated as safety issue: No ]

Estimated Enrollment: 75
Study Start Date: June 2010
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: CyPass 2FX Micro-stent Device: CyPass 2FX Micro-Stent
The CyPass 2FX Micro-Stent is a small tube with a through-lumen designed to redirect aqueous fluid from the front of the eye into the back of the eye. The CyPass 2FX has slightly different fixation and drainage design features than the CyPass 3FX.
Other Name: CyPass System 211

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of POAG
  • Medicated IOP ≥ 21 and ≤ 35 mmHg
  • Use of 1 - 4 topical IOP lowering medications

Exclusion Criteria:

  • Acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma
  • Use of oral hypotensive medication treatment for glaucoma
  • Previous incisional glaucoma surgery, or any combined cataract-glaucoma procedure
  • Clinically significant ocular pathology other than POAG
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01166659

Locations
Austria
University Eye Clinic
Salzburg, Austria
Bulgaria
Specialized Hospital for Active Treatment of Ophthalmologic Diseases
Sofia, Bulgaria
Germany
Schlosspark-Klinik, Department of Ophthalmology
Berlin, Germany
Augenklinik Cham
Cham, Germany
Klinik fur Augenheilkunde, Campus Lubeck
Lubeck, Germany
Klinik for Augenheilkunde - Dietrich Bonhoeffer Klinikum
Neubrandenburg, Germany
Spain
Institut Catala de Retina
Barcelona, Spain
San Carlos Clinical Hospital
Madrid, Spain
Sponsors and Collaborators
Transcend Medical, Inc.
Investigators
Study Chair: Tsontcho (Sean) Ianchulev, MD, MPH Transcend Medical, Inc.
  More Information

No publications provided

Responsible Party: Transcend Medical, Inc.
ClinicalTrials.gov Identifier: NCT01166659     History of Changes
Other Study ID Numbers: TMI-10-03
Study First Received: July 14, 2010
Last Updated: July 3, 2012
Health Authority: Germany: Ethics Commission
Austria: Ethikkommission
Bulgaria: Ministry of Health

Keywords provided by Transcend Medical, Inc.:
Glaucoma
Glaucoma device
Glaucoma surgery
Intraocular pressure

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on July 28, 2014